Dentsply Sirona digit Power User manual

digit Power®
Dispenser
Dispensador
Applicateur
Dispenser
Sistema di estrusione
OPERATION MANUAL - ENGLISH - 2
MANUALD E USO - ESPAÑOL - 20
MANUEL D'UTILISATION – FRANÇAIS - 39
BEDIENUNGSANLEITUNG – DEUTSCH - 58
MANUALE D’USO – ITALIANO - 77

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Table of Contents-English
1. PRODUCT DESCRIPTION ........................... 2
1.1 Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
1.2 Contraindications .................................2
1.3 Delivery Forms ...................................2
1.4 Compatible Materials ..............................2
2. GENERAL SAFETY NOTES. . . . . . . . . . . . . . . . . . . . . . . . . . 2
2.1 Warnings ........................................2
2.2 Precautions ......................................3
2.3 Adverse reactions ................................3
2.4 Storage conditions ...............................3
3. STEP-BY-STEP INSTRUCTIONS ...................... 4
3.1 Description of digit Power® Dispenser ...............4
3.2 Unpacking the System ............................5
3.3 digit Power® Dispenser Installation .................5
3.4. Charging the Handpiece and
Optional Wireless Foot Control ...................5
3.5 Synchronizing the Handpiece
and Optional Wireless Foot Control ...............6
3.6. Preparation for Use ..............................6
3.7 Loading the digit Power® Dispenser ................9
3.8 Dispenser operation ..............................9
3.9 Dispenser disassembly/plunger retraction ...........11
4. HYGIENE & MAINTENANCE. . . . . . . . . . . . . . . . . . . . . . . . . 11
5. TECHNICAL SPECIFICATIONS ...................... 14
6. CLASSIFICATIONS ................................ 14
7. SYMBOL IDENTIFICATION .......................... 15
8. DISPOSAL OF UNIT ............................... 16
9. ELECTRO-MAGNETIC COMPATIBILITY PRECAUTIONS . . 16
10. TROUBLESHOOTING ............................. 18
11. SERIAL NUMBER ................................. 19
12. WARRANTY ..................................... 19
13. TECHNICAL SUPPORT ............................ 19
OPERATION MANUAL – ENGLISH
Caution: For dental use only.
U.S.A.: Rx only.
1. PRODUCT DESCRIPTION
digit Power® Dispenser is a battery powered dental material dispensing
handpiece for precision intraoral placement of dental materials delivered via digit
Power® cartridges. digit Power® Dispenser is designed to improve the ergonomics
of material delivery when compared to conventional, mechanical systems while
allowing for easy and precise intraoral placement of dental materials. Portability
and versatility are built into the design of digit Power® Dispenser with long
battery life, multiple speed options on the handpiece and an optional Bluetooth®
wireless foot control for full variable speed.
digit Power® Dispenser has a built-in, automatically activated timer, for
convenient monitoring of work time (WORK TIME) of material while dispensing,
and dispensed material set time/mouth removal time (SET TIME/MRT). Timer
preset modes correspond to Aquasil® Ultra+ Smart Wetting® Impression Material
FAST SET and REG SET. A convenient user-specified timer option is also built
into the handpiece.
1.1 INDICATIONS
The digit Power® Dispenser is indicated for intraoral delivery of materials
provided in digit Power® cartridges.
The digit Power® Dispenser is readily suitable for:
• Delivery of low viscosity Aquasil® Ultra+ Smart Wetting® Impression Material in
digit Power® cartridges for single or multiple preparation impression technique.
1.2 CONTRAINDICATIONS
None known.
1.3 DELIVERY FORMS*
*Some delivery forms may not be available in all countries
digit Power® Dispenser is available as a complete unit, with battery charging
stand.
Product components:
• Handpiece Assembly
• Removable Autoclavable Cartridge Cap
• Charging Base Assembly
• Wall Plug-in Power Supply
• International Power Adapters
Available accessories:
• Wireless foot control for dispensing speed control
• Disposable Polyethylene Barrier Sleeves
1.4 COMPATIBLE MATERIALS
The digit Power® Dispenser is compatible with materials provided in digit Power®
cartridges.
Materials not provided in digit Power® cartridges are not intended to be used
with the digit Power® Dispenser.
See the Complete Directions for Use of selected material for compatibility and
use.
2. GENERAL SAFETY NOTES
Be aware of the following general safety notes.
Safety alert symbol
This is the safety alert symbol. It is used to alert you to potential
personal injury hazards. Obey all safety messages that follow this
symbol to avoid possible injury.
2.1 Warnings
• To prevent damage, charge the handpiece using only the digit Power®
Dispenser charging base for handpiece and power supply and cord.
• Sterilizing the handpiece will cause component damage to the handpiece
and the sterilizing equipment, and may cause personal bodily injury.
• The cartridge cap must be steam sterilized before first use and between
patients to prevent patient cross contamination. See Section 4 for the
Hygiene and Maintenance.
• It is the responsibility of the Healthcare Professional to determine the
digit Power®
Dispenser

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appropriate uses of this product and to understand:
• the health of each patient
• the dental procedures being undertaken
• applicable industry and governmental agency recommendations for
infection control in dental healthcare settings
• requirements and regulations for safe practice of dentistry
• these Directions for Use in their entirety
• Per FCC Part 15.21, changes or modifications not expressly approved by
the party responsible for compliance (i.e., the manufacturer) could void
the user’s authority to operate this equipment.
• Failure to follow recommendations for environmental operating
conditions (see Section 5 and 9 for Specifications) could result in injury
to patients or users.
• Inspect the handpiece system before each use for worn, loose or
damaged parts.
• To prevent bodily injury and damage to the device, do not sterilize the
handpiece, charging base for handpiece, optional wireless foot control
or power supply and cord. Disinfect the handpiece and charging base
for handpiece using only the tested and approved disinfectants listed in
Section 4, Hygiene and Maintenance.
• The handpiece, optional wireless foot control , charging base for
handpiece and power supply and cord are not waterproof. To prevent
damage to the equipment, contamination or bodily injury, do not
immerse any of these components in water or a chemical solution.
• Use only components and accessories listed in Section 3.2 of this
manual. Failure to do so will void the warranty, may decrease system
performance, may lead to unsafe operation, may negatively affect
Electro-Magnetic Compliance performance and result in non-compliance.
• There are no user-serviceable items in the handpiece, power supply and
cord, cartridge cap, optional wireless foot control or charging base for
handpiece. Opening any of these units may result in unsafe operation and
will void the warranty.
• According to IEC 60601-1/UL60601-1, this device must not be used in the
presence of a flammable anesthetic gas mixed with air, oxygen, or nitrous
oxide. (Note: nitrous oxide by itself is not a flammable anesthetic gas.).
• User should not touch the patient and the accessible charging base
contacts or USB contact simultaneously.
2.2 Precautions
• This product is intended to be used as specifically outlined in the
Directions for Use. Any use of this product inconsistent with the Directions
for Use is at the discretion and sole responsibility of the practitioner.
• Wear suitable protective eyewear, mask, clothing and gloves. Protective
eyewear is recommended for patients.
• Always insert the cartridge/mixtip assembly into the cartridge cap first and
then connect the cartridge cap to the handpiece, otherwise a malfunction
may occur.
• Ensure plungers are fully retracted by visual inspection prior to placing
cartridge cap/cartridge/mixtip assembly onto handpiece.
• Improper alignment of the cartridge within the cartridge cap, and/or
the cartridge cap and handpiece may result in a device malfunction.
An audible click will be heard when the cartridge cap is secured to the
handpiece.
• Devices marked “single use” on the labeling are intended for single use
only. Discard after use. Do not reuse in other patients in order to prevent
cross-contamination.
• As an additional precautionary measure, digit Power® Dispenser may be
protected from gross debris but not from all contamination by applying
a protective barrier. Reprocess reusable components after each use
according to instructions in Section 4, Hygiene and Maintenance section.
• Do not autoclave the digit Power® Dispenser handpiece.
• Do not spray disinfectant or other fluids directly onto the handpiece,
optional wireless foot control , charging base for handpiece, or power
supply and cord to avoid liquid from pooling on the component. The user
should spray solution onto a cloth or use a wipe to disinfect items per the
instructions in Section 4.
• Prevent liquids from entering openings on the handpiece and charging
base.
• Ensure handpiece and charging base are fully dry before placing
handpiece into charging base.
• If plungers do not retract automatically at defined limits, or when manually
commanded (see Operation Section 3.8), allow cartridge to empty away
from patient field, turn unit off (see Operation Section3.6) and return unit
for service. Do not attempt to disassemble or use further.
• Use only material in designated digit Power® cartridges.
Suitable cartridges will be marked PWR on tab. Do
not use digit Power® Dispenser with materials in digit®
Targeted Delivery System cartridges designed for manual
dispensing. Device and cartridge malfunction may occur.
• The handpiece is designed to be lube-free. Lubrication
may cause damage to the handpiece.
• Oil and/or dirt may damage the motor, electronics and
battery located inside the handpiece.
• The batteries are not user replaceable. If not functional,
the units should be returned to the listed repair center for
replacement.
• Do not place the system on or next to a radiator or other
heat source. Excessive heat may damage the system’s electronics.
• Inadvertent system shutdown may occur in the presence of strong non-
compliant radio frequency-generating components.
2.3 Adverse reactions
None known.
2.4 Storage conditions
Inadequate storage conditions may shorten the shelf life and may lead to
malfunction of the product.
• Store at temperatures between -20ºC/50ºC.
• Use the product at room temperature.
• Protect from moisture.
• Store at relative humidity range 5 – 95% (non-condensing).

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3. STEP-BY-STEP INSTRUCTIONS
3.1 Description of digit Power® Dispenser
Removable, Autoclavable Cartridge Cap
Charging Base for Handpiece
(See Section 3.4)
Charge Indicator
(Charging - See Section 3.4)
(Synchronization - See Section 3.5)
(Operation - See Section 3.8)
Wireless Foot Control (optional)
(Charging - See Section 3.4)
(Synchronization - See Section 3.5)
(Operation - See Section 3.8)
On/Off/Mode Button
Mode Indicator
Handpiece
(See Section 3.6)
Mixing Tip
Removable, Autoclavable
Cartridge Cap
Dispensing Buttons
Cartridge Cap
Lock
On/Off/Mode Button
Charging Base
Charge Indicator

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3.2 Unpacking the System
As you unpack your digit Power® Dispenser, verify that the following components and accessories are included:
System:
1- Handpiece with 1 preassembled cartridge cap
2- Cartridge caps
1- Charging Base for Handpiece
1- Power Supply and Cord
1- Package of 50 Disposable Polyethylene Barriers (Single Use)
1- Package International Power Adapters
Optional Wireless Foot Control
(Available Separately):
1- Foot Control
1- Power Supply and Cord
1 Package- International Power Adapters
3.3 digit Power® Dispenser Installation
System Setup
• Both the handpiece and optional wireless foot control must be charged for at least 90 minutes prior to first use.
3.4. Charging the Handpiece and Optional Wireless Foot Control
• When the battery icon is empty (no bars), the handpiece must be charged.
• When the charge indicator light on the optional wireless foot control is solid orange, the foot control must be charged.
• A fully discharged handpiece or foot control will need approximately 3 hours to fully recharge.
When the handpiece is not in use, storage in the charging base is recommended. The handpiece has built-in safety circuitry that prevents
overheating or overcharging. The battery does not have “memory” and will always accept a full recharge.
1. Plug the power supply into a wall outlet.
Electrical Malfunction
• Connect to single phase AC power 100-240V power only. Otherwise, malfunction will occur.
• Do not unplug the power supply by pulling on the cord.
• Ensure Handpiece, charging base and optional wireless foot control are clean and fully dry before connecting power and/or inserting
handpiece into charging base.
2. Plug the power supply cord into the charging base (for handpiece charging) or directly into the optional wireless foot control
(for foot control charging).
3. Insert the handpiece into the charging base. Ensure contacts are clean and aligned. Handpiece should be stable in
the charging base.
A successful connection is shown as follows:
– The battery icon flashes and scrolls through all states of charge for handpiece. Battery icon will be solid when handpiece battery is at full
charge.
– A solid Green Charge Indicator on top of the optional, wireless foot control appears.
Unplug the power supply from the wall outlet (power mains) to remove all power to the unit being charged.
Cross-contamination
Do not reuse single use products. Dispose of in accordance with local regulations.
Reprocess reusable products as described in Section 4, Hygiene and Maintenance section.
Cartridge caps should be steam-autoclave sterilized prior to first use.
Reprocessing is mandatory following each use thereafter.
Additional Cartridge caps are available for purchase.

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• The handpiece should be recharged after each full day’s use.
• If necessary, the handpiece may be “quick charged” for a single use in 15 minutes.
• When in the charging base, the handpiece motor is not allowed to operate.
• When fully charged, the battery icon in the display will be solid (not scrolling).
• The optional wireless foot control should be recharged when the charge state indicator light is solid orange.
• The foot control may be operated while charging.
CHARGE STATUS FOR FOOT CONTROL
Solid green light 95-100%
Blinking green light 30-95%
Solid orange light Less than 30%
3.5 Synchronizing the Handpiece and Optional Wireless Foot Control
Follow this procedure when:
• The optional wireless foot control or handpiece is replaced for any reason.
• The handpiece and optional wireless foot control do not seem to be communicating properly.
Handpiece must be placed in charging base and connected to power supply in order to pair with the foot control.
1. Place the optional wireless foot control within 10 feet of the charging base for handpiece.
2. Invert the optional wireless foot control.
3. Ensure foot control is on. To turn foot control on, depress the power button for 1 second.
4. Depress the “Sync” button on the selected optional wireless foot control for at least 2 seconds and release.
5. Immediately depress the On/Off/Mode button on the handpiece once for 3 seconds and release to complete pairing.
6. A successful sync is indicated by the appearance of the Bluetooth® icon on the handpiece changing from flashing to solid, and the sync indicator light on the foot
control is blinking green.
7. The Bluetooth icon will change to a “foot on the pedal” when the paired foot control is pressed.
Synchronization Indicator Status (Handpiece and Optional Wireless Foot Control Sync Mode)
Device Indicator Ready to Pair Successful Pairing Failed Pairing
Handpiece Display Bluetooth Icon Blinking Solid Bluetooth Icon Bluetooth Icon Gone
Foot Control LEDs Blinking Blue Blinking Green Blinking Orange
3.6. Preparation for Use
1. Position the optional wireless foot control for use, ensuring that the floor is level.
2. Ensure that the handpiece (including cartridge cap) has been reprocessed according to Section 4, Hygiene and Maintenance.
Cross-contamination
Ensure the disposable polyethylene barrier has been correctly applied over the entirety of the handpiece and cartridge cap, with mixtip and
intraoral tip protruding through hole of barrier, before beginning a procedure.
This Polyethylene Sleeve does not replace cleaning and disinfection of the dental instruments. Please clean and reprocess dental instruments after
each patient as described in Section 4, Hygiene and Maintenance.

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3. Description of Display Graphics
On/Off Power Button, Timer Mode selection button
FAST
SET Fast Set Timer Mode
REG.
SET Regular Set Timer Mode
WORK
TIME User Set Timer Mode, Work Time adjustment screen
SET
TIME User Set Timer Mode, Set Time adjustment screen
Battery level status icon
►
►► Icon reminds user to use the ► button to increase User Set times and the ►► button to decrease User Set times
Bluetooth logo, indicates pairing status with optional wireless foot control
SHUT
DOWN Device is powering off
ERROR CODE 1:
TEMPERATURE Unit is in overheated state
ERROR CODE 2:
DRIVE TRAIN Unit drive train is in error state
ERROR CODE 3:
POWER SUPPLY Unit power supply is in error state
ERROR CODE 4:
SELF TEST Unit self-diagnostic check is in error state
4. Powering the Handpiece On/Off
• To power on, press and hold the power/mode selector button for approximately 2 seconds.
• Handpiece will confirm proper function with slight advance and retraction of plungers.
• Refer to the table for handpiece display of battery charge level.
HANDPIECE DISPLAY BATTERY STATES
Indicator Light Percent of icon Degree of Charge
100 % 80-100%
75 % 60-79%
50 % 40-59%
25 % 20-39%
• To power off, press and hold On/Off/Mode selector button.
2''

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digit Power® Dispenser performs a self-diagnostic check upon start-up to ensure all systems are functioning properly.
1. If the display screen shows an error code (see Graphics description), power the handpiece off by pressing and holding the power/mode selector
button.
2. Ensure the plungers are not fouled or blocked. Remove debris if necessary. Do not attempt to remove debris if plungers are in motion.
3. Attempt to power the handpiece on. If the unit display is normal, the handpiece has self-corrected the error and is fully functional.
4. If ERROR CODE 1: TEMPERATURE is still displayed, unit may be in an overheating condition. Power the handpiece off, and remove handpiece
to a cool, dry area. Allow handpiece to cool for 10 minutes, then power the handpiece on. If the unit display is normal, the handpiece has self-
corrected the error and is fully functional. Avoid exposing handpiece to conditions that caused the overheating.
5. If any error code (including ERROR CODE 1: TEMPERATURE after 10 minute cool-down as described above) is still present, note the code, power
the handpiece off, and contact Dentsply Sirona Technical Support. Do not attempt any further disassembly or remedial actions. Do not attempt
to use the handpiece.
5. Adjusting the Integrated Timer
• The integrated timer assists in ensuring intraoral placement of impression material is completed within
material intraoral work time.
• The integrated timer automatically counts down the time from first dispensing until the recommended
setting time/mouth removal time (SET TIME /MRT).
• There are three timer modes for digit Power® Dispenser with material
work and set time notifications. “FAST SET” and “REG. SET” are preprogrammed
to coincide with the work/set times for Aquasil® Ultra+ Smart Wetting® Impression Material
in digit Power® cartridges. ”USER SET” allows the user to define work and set time
for the material being used.
First Use or to Change Settings
• Display and handpiece default to the “FAST SET” timer and audible signals on first use.
• For subsequent uses, the handpiece will default to the previously used setting.
• If the handpiece is paired with the optional wireless foot control, the Bluetooth icon will display.
• To move between each mode, press and release the power/mode select button.
o FAST SET - (intraoral WORK TIME = 0:35, SET TIME/MRT = 2:30) Corresponding to Aquasil Ultra+ Material Fast Set.
o REG. SET- (intraoral WORK TIME = 1:10, SET TIME/MRT = 5:00) Corresponding to Aquasil Ultra+ Material Regular Set.
o USER SET - User defined WORK TIME and SET TIME/MRT.
• User Set - user specifies Work Time and Set Time
1. Scroll by pressing and releasing the power/mode button until the “WORK TIME” displays. “0:00” will be
flashing and the “+ -“ adjust icon will appear.
2. Press the forward-located Slow ► to add time or Fast ►► speed buttons to subtract time to set the Work
Time.
3. Press and release the power/mode selection button. “SET TIME” will display. The specified work time from
the step above will be flashing and the “+ -“ adjust icon will appear.
Note – pressing and holding either Slow ► or Fast ►► speed buttons will increment or decrement time by
10 seconds respectively.
4. Press the forward-located Slow ► to add time or Fast ►► speed buttons to subtract
time to set the Set Time.
[Notice] – If the User defined Set Time is adjusted to be less than the User defined
Work Time, the timer will disregard the longer user defined Work Time setting and
use the Set Time for both times for audible notifications and automatic plunger retraction .
5. Press and release the power/mode selection button. “USER SET” will display. The time displayed will be the
user defined Set Time from step 4 above.
In the User Defined mode, the settings may be left to 0:00.
• The handpiece will function normally, with the audible signals disabled.
• The timer counts up from 0:00 showing elapsed time from initial dispensing.

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3.7 Loading the digit Power® Dispenser
To test functionality pre-operative, please follow directions below, extruding one cartridge, prior to use on patients.
1. Prepare a digit Power® cartridge for use by
snapping the circular disk off the cartridge.
2. Insert unit dose cartridge into mixing tip.
Ensure both cartridge spurs fully lock into the
square holes on the side of the mixing tip.
3. With the cartridge cap removed from the
handpiece, insert the digit Power® cartridge
mixing tip assembly into the cartridge cap.
4. Ensure the digit Power® cartridge is locked
into the cartridge cap by the retaining tab.
If cartridge is misaligned (retaining tab not
parallel to cartridge) cartridge cap cannot be
seated onto handpiece.
5. Ensure plungers are fully retracted. Visually
inspect and confirm plunger retraction before
attempting to seat the cartridge cap.
6. Place cartridge cap with fully seated
cartridge in place on handpiece so that the
locks slide into place. An audible click will
be heard when the cartridge cap is properly
secured to the handpiece. Tug on the seated
cartridge cap to confirm secure attachment.
Improper Assembly – Device Malfunction
• Ensure plungers are fully retracted before placing cartridge cap onto handpiece.
• Ensure the cartridge is fully seated into the cartridge cap.
• Ensure cartridge/cap assembly is fully seated onto the handpiece.
• Audible clicks may be heard to denote proper assembly.
7. Place a protective barrier sleeve over Dispenser.
8. Verify that all parts of the Dispenser are securely attached before use.
9. Charge Status: Handpiece Charge Level must display at least 1 bar. Refer to Section 3.4, Charging the Handpiece.
3.8 Dispenser operation
• The handpiece has two forward speed dispensing buttons for finger operation, operating discrete Slow and Fast speeds.
• The optional wireless foot control allows continuously variable speed control throughout the entire handpiece speed range.
The wireless foot control connects to the handpiece via Bluetooth. Like all wireless devices, the connection is subject to interruption by
environmental interference. If the connection with the handpiece is lost, complete the procedure using the manual speed buttons. When
convenient, re-pair the wireless foot control and handpiece as outlined in Section 3.5.
1. Ensure the integrated timer is properly adjusted for the selected material.
2. Activate the Dispenser by depressing the fast or slow handpiece buttons, or depress the optional wireless foot control and, away from the patient,
bleed a small amount through the tip to assure proper flow and a good mix.
3. Follow Directions for Use for selected material placement.
4. Speed may be changed during operation by repositioning finger from one button to the other. Speed may be varied with the wireless foot control by
stepping harder or softer on the control at any time during operation.

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Start out using the slowest speed setting and adjust upward as desired after becoming familiar with the device.
5. Upon initiating a dispensing cycle (when material enters the mixing tip), a timer counts down the Work Time and provides an audible notification at
three time points:
o 10 seconds before WORK TIME OR if plungers are nearing full extension, cartridge nearly empty (whichever comes first), 3 short beeps.
o At WORK TIME, 1 long beep – Intraoral placement should have been completed, tray should be seated.
o At SET TIME, 3 long beeps– Impression may be removed from the mouth.
(See Complete Directions for Use of selected material for material work and set times)
Notification Signal Procedure Time
3 short beeps Nearing Intraoral Worktime or end of cartridge
1 long beep At Intraoral Worktime
3 long beeps At Set Time/MRT
• If device is operating in user set mode, with WORK TIME/SET TIME = 0:00, there will be no timing notification beeps and the clock will count up
once material begins dispensing, up to 9:59 (unless restarted by reloading and extruding another cartridge).
6. Stop the flow of material by releasing the button or stepping off of the wireless foot control. The digit Power® Dispenser will slightly retract the
plungers to reduce continued material flow. Material dispensing may be restarted by re-depressing button or foot control.
Impression Defect-exceeding work time
• Do not restart dispenser or attempt to place material after expiration of selected material work time.
• Do not attempt to remove and reload cartridge during a single clinical procedure.
• Ensure the loaded tray has been seated within the intraoral WORK TIME.
• Exceeding intraoral WORK TIME of syringed material before seating tray may lead to impression defects,
requiring repeat of procedure.
• See Complete Directions for Use of selected material.
7. Integrated timer – automatic plunger retraction
• FAST SET, REG. SET, User Defined WORK TIME/SET TIME ≠ 0:00
o These settings are designed for dispensing one cartridge only during a procedure.
o Once material is extruded, starting timer, the mode selection is disabled, and the timer may only be interrupted by power cycling the
handpiece (power off, power back on).
o Plungers will automatically retract to fully retracted position when:
• Timer reaches 1:00 (Fast Set) or 2:00 (Regular Set) or 0:00 (User defined ≠ 0:00) OR
• 10 seconds after cartridge is emptied (plungers fully extended) regardless of timer OR
• User simultaneously presses and releases Slow ► and Fast ►► speed buttons OR
• Handpiece is power cycled off/on OR
• Handpiece is placed in charging base
• User Defined WORK TIME/SET TIME = 0:00
o This setting will allow dispensing of more than one cartridge during a procedure.
o [NOTICE] – User must ensure material(s) are used within allowable work times. See complete Directions for Use of selected material.
o Once material is extruded, starting timer up, the mode selection is disabled. However, user may manually retract (simultaneously press and
release Slow ► and Fast ►► speed buttons) and restart the timer by loading and dispensing another cartridge.
If manually retracted, reloaded and second cartridge dispensed, the timer restarts counting up from 0:00, timing the second dispensed cartridge.
Timing of first dispensed cartridge is no longer tracked.
o Plungers will automatically retract to fully retracted position when
• Timer reaches 9:59 OR
• 10 seconds after cartridge is emptied (plungers fully extended) OR
• User simultaneously presses and releases Slow ► and Fast ►► speed buttons OR
• Handpiece is power cycled off/on OR
• Handpiece is placed in charging base
• ALL MODES/TIMER SETTINGS
o Plungers will automatically retract to fully retracted position when
• 10 seconds after cartridge is emptied (plungers fully extended) OR
• User simultaneously presses and releases Slow ► and Fast ►► speed buttons OR
• Handpiece is power cycled off/on OR
• Handpiece is placed in charging base OR
• Timer reaches 1:00 (Fast Set) or 2:00 (Regular Set) or 0:00 (User defined ≠ 0:00)

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8. Dispenser has a built-in safety mechanism to prevent cartridge over pressurization. If material is partially or completely set and/or cartridge is
blocked, plungers will slow or retract. Manually retract plungers by simultaneously pressing and releasing Slow ► and Fast ►► speed buttons, and
replace cartridge/mix tip assembly.
3.9. Dispenser disassembly/plunger retraction
1. Prior to disassembly, ensure Dispenser plungers are fully retracted.
• Simultaneously press and release both Slow ► and Fast ►► speed forward speed buttons on the handpiece to retract plungers.
• Plungers will automatically retract as outlined above without additional user input.
2. To disassemble: Press both side cartridge cap locks to release.
Withdraw cartridge cap/cartridge/mix tip straight off.
Do not twist the cartridge cap while removing.
Slightly depress the retaining tab and withdraw the used cartridge/mix tip assembly.
3. To prepare/reprocess contaminated components for reuse, see Hygiene & Maintenance Section 4.
4. HYGIENE & MAINTENANCE
Cross-contamination - Infection
• Do not reuse single use products. Dispose of in accordance with local regulations.
• The barrier is designed for single use and must be disposed of after each use in accordance with local regulations.
The barrier is not a replacement for cleaning, disinfection, and sterilization.
• Reprocess reusable products as described below.
NOTICE
Wrong cleaning or disinfection method.
Damage to the device.
1. Always disassemble digit Power® Dispenser before final reprocessing.
2. Do not clean or disinfect with aggressive agents (e.g. solutions based on orange oil or acetone).
3. Start reprocessing within 1 hour after use.
4. Repeated liquid contact may damage labels. Vigorous wiping can destroy the label. Wipe device labels gently.
For Manual Cleaning and Disinfection
• Discard used gloves according to local regulations.
• Disinfect hands with an appropriate bactericidal, virucidal, and fungicidal hand disinfectant solution according to local regulations. Use according to
disinfectant solution manufacturer’s Instructions for Use.
• Use a new clean pair of examination gloves.
INSTRUCTIONS FOR CLEANING, DISINFECTING AND STERILIZING CARTRIDGE CAP
Warnings • These instructions are for use ONLY on the Cartridge Cap. The handpiece and charging base should be disinfected
according to the procedures in the “Instructions for Cleaning and Disinfecting Other Parts” section.
• Steam autoclaving sterilization is appropriate for the Cartridge Cap.
• Do not allow the device to exceed 137° C.
Limitations on
Reprocessing
• Repeated processing has minimal effect on the cartridge cap.
• The cartridge cap can be subjected to the manual cleaning and disinfection process up to 800 times.
• The cartridge cap can be subjected to the automated washer/disinfector process up to 800 times.
• The cartridge cap can be subjected to the steam autoclave sterilization process up to 800 times.
• Cold liquid immersion disinfection/sterilization, chemical vapor sterilization, and dry heat sterilization methods have not
been tested or validated for efficacy and are not recommended for use.
Point of Use • Remove protective barrier and discard according to local regulations.
• Remove excess soil with disposable cloth / paper wipe in combination with an alcohol-based, tuberculocidal, quaternary
ammonium solution with a label claim for cleaning (e.g., VoloWipes® Disinfecting/Cleaning/Deodorizing Wipes).
• Reprocess dispenser handpiece as outlined in the “Instructions for Cleaning and Disinfecting Other Parts” section.
Prior to Cleaning and Disinfection of the Cartridge Cap, the digit Power® Dispenser should be disassembled:
1. Remove cartridge cap: Press both side cartridge cap locks to release. Withdraw cartridge cap/cartridge/mix tip
straight off. Do not twist the cartridge cap while removing.
2. Slightly depress the retaining tab and withdraw the used cartridge/mix tip assembly. Do not attempt to refill or
consolidate used cartridges. Dispose of used cartridge/mix tip assembly in accordance with local regulations.
It is recommended that the Cartridge cap and handpiece be reprocessed as soon as is reasonably practical following use.

12
Containment and
Transportation
No particular requirements. Handle with care.
Cleaning and Disinfection:
Automated
Thermal disinfector: Manufacturer’s specification according to DIN EN ISO 15883. Cleaning program (A0 value > 600 or, at
least 1 min at 90˚C/194˚F) as indicated by the manufacturer in the operating instructions.
Follow manufacturer’s recommendation for use of detergent and neutralizer, observing concentrations and contact times.
Cleaning and Disinfection
(Low-level):
Manual
As an alternative to automated cleaning and disinfection, the cartridge cap has to be cleaned by scrubbing with hot
water and enzymatic detergent solution prepared according to the manufacturer’s instructions (e.g., Resurge® Instrument
Cleaning Solution).
• Immerse cartridge cap in the detergent solution. Clean with a soft brush.
• Rinse under running potable water.
• Dry with a lint-free single-use cloth.
Follow by disinfection as outlined below:
• Wipe all device surfaces with a single-use cloth in combination with an alcohol-based, tuberculocidal, quaternary
ammonium solution (e.g., VoloWipes® Disinfecting/Cleaning/Deodorizing Wipes).
• Thoroughly disinfect the surface with the soaked cloth, paying special attention to any cavities and holes. Ensure the
entire surface remains wet for the entirety of the required contact time in accordance with the disinfectant solution
manufacturer’s instructions for use.
• Rinse for 30 seconds under running potable water.
• Dry with a lint-free single-use cloth.
Packaging Paper / plastic steam sterilization pouches (e.g., AssurePlus® Sterilization Pouches) may be used, but are not required.
Sterilization After Cleaning and Disinfecting, steam autoclaving is required.
Gravity Steam Sterilization:
• Full Cycle: 132˚C for 15 minutes.
Prevacuum Steam Sterilization:
• Full Cycle: 132˚C for 4 minutes or 134˚C for 3 minutes.
Steam Flush Pressure Pulse Sterilization:
• Full Cycle: 132˚C for 3.5 minutes.
Follow manufacturer’s instructions for loading and operation cycle.
Drying Use the drying cycle of the autoclave, minimum 30 minutes.
Allow the cartridge cap to fully air dry before storage.
Maintenance Visually inspect to ensure that all contamination has been removed. If the cartridge cap is discolored, damaged, worn, or
distorted it should be discarded.
No additional maintenance or lubrication is recommended.
Storage Store the cleaned, disinfected and sterilized cartridge cap at room temperature, away from moisture or excessive humidity.
Instruments steam autoclaved bagged should remain bagged until ready for use. Prior to subsequent re-use, inspect the
sterilization pouch and the cartridge cap. If the integrity of the sterilization pouch has been compromised, the cartridge
cap must be reprocessed prior to use. Instruments steam autoclaved unwrapped should be used immediately.
Dispenser handpiece and Charging Base should be cleaned, disinfected and dried as outlined in the section below prior to
storage.
Manufacturer Contact Within the United States, call Dentsply Sirona at 1-302-422-4511. For areas outside the United States, contact your local
Dentsply Sirona representative.

13
INSTRUCTIONS FOR CLEANING AND DISINFECTING OTHER PARTS (DISPENSER HANDPIECE , CHARGING BASE)
WARNINGS • The digit Power® Dispenser handpiece and charging base for the handpiece are not sterilizable by autoclave.
• Intermediate-level disinfection is appropriate for the digit Power® Dispenser handpiece and charging base for the
handpiece.
• Do not autoclave in steam autoclave.
• Do not clean/disinfect in automated washer/disinfector.
• Do not immerse in liquid.
Limitations on
Reprocessing
• Repeated reprocessing has minimum effect on these instruments. End of life is normally determined by wear and
damage due to use.
• The digit Power® Dispenser handpiece and charging base can be subjected to the manual cleaning and disinfection
process up to 3120 times.
• Cold liquid immersion disinfection/sterilization, chemical vapor sterilization, and dry heat sterilization methods have not
been tested or validated for efficacy and are not recommended for use.
The Cartridge cap must be steam autoclave sterilized. Refer to cleaning, disinfection and steam sterilization procedures for
the autoclavable cartridge caps in the section above.
Point of Use • Remove protective barrier and discard according to local regulations.
• Remove excess soil with disposable cloth / paper wipe in combination with an alcohol-based , tuberculocidal, quaternary
ammonium solution with a label claim for cleaning (e.g., VoloWipes® Disinfecting/Cleaning/Deodorizing Wipes).
• Following handpiece Cleaning outlined below, the digit Power® Dispenser cartridge cap should be disassembled and
reprocessed as outlined above.
• Do not attempt further disassembly of handpiece or charging base.
It is recommended that the Cartridge cap and handpiece be reprocessed as soon as is reasonably practical following use.
Containment and
Transportation
No particular requirements. Handle with care.
Cleaning and Disinfection:
Automated
Do not use automated washer/disinfectors for reprocessing digit Power® Dispenser handpiece or charging base.
Component damage will occur.
Cleaning and Disinfection
(Intermediate-level):
Manual
• The digit Power® Dispenser handpiece and charging base have to be cleaned by scrubbing with a pre-impregnated wipe
or disposable towel soaked with an alcohol-based , tuberculocidal, quaternary ammonium solution with a label claim for
cleaning (e.g., VoloWipes® Disinfecting/Cleaning/Deodorizing Wipes).
• Remove all visible soil, ensuring fluid penetrates all crevices. Do not allow solution to penetrate the casing.
Remove Cartridge Cap and reprocess as outlined above.
• After cleaning and disassembling Cartridge Cap, thoroughly wipe all device surfaces with a new single-use cloth in
combination with an alcohol-based, tuberculocidal, quaternary ammonium solution (e.g., VoloWipes® Disinfecting/
Cleaning/Deodorizing Wipes) approved according to local regulations, and use according to disinfectant solution
manufacturer’s Instructions for Use. Pay special attention to seams, areas around buttons, window, handpiece dock and
crevices where the cap attaches.
• Allow the handpiece and charging base to air dry.
• For the handpiece, rinse by wiping with a sterile, clean, lint-free cloth dampened with distilled water.
Packaging No particular requirements.
Sterilization Sterilization is not allowed. No methods have been validated.
Do not subject components to steam autoclaving or liquid chemical sterilant immersion. Component damage will occur.
The cartridge cap must be steam autoclave sterilized. Refer to steam sterilization procedures for the autoclavable cartridge
caps in the section above.
Drying Dry the components with a sterile, clean, lint-free cloth. Allow the components to fully air dry before storage.
Maintenance Visually inspect to ensure that all contamination has been removed.
Visually inspect power supply and cord for damage.
Components that are damaged, worn, or distorted should be discarded.
No additional maintenance or lubrication is recommended.
Storage Store the digit Power® Dispenser handpiece and charging base at room temperature, away from moisture or excessive
humidity.
Cartridge cap should be cleaned, disinfected, sterilized and dried as outlined above prior to storage.
Manufacturer Contact Within the United States, call Dentsply Sirona at 1-302-422-4511. For areas outside the United States, contact your local
Dentsply Sirona representative.

14
Incidental surface contact of the optional wireless foot control, power supply and cord with water, soap or a water-based hospital-level disinfection solution
will not damage the material of construction. Do not allow any solution to penetrate the casing.
The instructions provided above have been validated by Dentsply Sirona as being capable of preparing a medical device for re-use. It remains the
responsibility of the processor to ensure that the processing is actually performed using equipment, materials and trained personnel in the processing facility
to achieve the desired result. This requires validation and routine monitoring of the process. Likewise, any deviation by the processor from the instructions
provided should be properly evaluated for effectiveness and potential adverse consequences. Use of other reprocessing procedures/methods is at the
discretion and sole responsibility of the practitioner .
5. TECHNICAL SPECIFICATIONS
Power Supply manufacturer:
Power Supply model number:
GLOBTEK WR9QA1200USBNMEDRVB
AC Input Continuous (100-240 VAC)
AC Input Current Less than 0.7A
AC Input Phases Single
AC Input Frequency 50-60 Hz
AC Voltage Range for Power supply 120 – 240 V
DC Output Power 5W
DC Output Voltage and Current +5VDC at 1A
Output Regulation +/- 10%
Weight Handpiece with cartridge cap = 120 g
Foot Control = 200 g
Dimensions Handpiece with cartridge cap: L = 190 mm, W = 30 mm
Optional Wireless Foot Control: W = 118 mm H = 40 mm
Remote Communication
Transmit/Receive
Frequency: 2405-2480 MHz
Power: 1mW
Channels: 40 (BLE)
Bandwidth 2 MHz
Operating Environment Ambient temperature: 10°C - 40°C
Relative Humidity: 5-95% (non-condensing)
Atmospheric Pressure: 80-106 kPa
Altitude: < 2,000 meters
Transport and Storage Conditions Ambient temperature: -20°C to 50°C
Relative Humidity: 5-95% (non-condensing)
Atmospheric Pressure: 50-106 kPa
Altitude < 5,000 meters
Optional Wireless Foot Control Protection Class IPX1.
Applied Parts Single-use disposable polyethylene barrier sleeve
Single-use disposable cartridge mixtip/intraoral tip assembly
6. CLASSIFICATIONS
Type of protection against electric shock: Class II
Degree of protection against electric shock: Type B Applied Part
Mode of operation for Handpiece: Operating, Charging, OFF
Mode of operation for Foot Control: OFF, Continuous
Settings for Handpiece 3 (Fast Set, Regular Set, User Set)
Degree of safety of application in the presence of a
flammable anesthetic mixture with air or with oxygen or
nitrous oxide:
Equipment not suitable for use in the presence of flammable mixtures
According to medical device directive: I (Rule 12) (IEC 60601) UL 60601-1
Pollution Degree Classification Pollution Degree 2
Overvoltage Category Category II (connected to wall outlet)

15
7. SYMBOL IDENTIFICATION
Keep Away
From Sunlight For Dental Use Only Keep Dry
www.dentsplysirona.com
www.dentsply.eu/ifu
50°C
122°F
Storage
Temperature
-20°C
4°F
Caution, consult
instructions for use Fragile Relative Humidity
%
5%
95%
Atmospheric
Pressure Limitation
80
kPa
106
kPa
5V-1A
137
13Va
Class II Equipment
Keep Away
From Sunlight For Dental Use Only Keep Dry
www.dentsplysirona.com
www.dentsply.eu/ifu
50°C
122°F
Storage
Temperature
-20°C
4°F
Caution, consult
instructions for use Fragile Relative Humidity
%
5%
95%
Atmospheric
Pressure Limitation
80
kPa
106
kPa
5V-1A
137
13Va
Type B applied part
Keep Away
From Sunlight For Dental Use Only Keep Dry
www.dentsplysirona.com
www.dentsply.eu/ifu
50°C
122°F
Storage
Temperature
-20°C
4°F
Caution, consult
instructions for use Fragile Relative Humidity
%
5%
95%
Atmospheric
Pressure Limitation
80
kPa
106
kPa
5V-1A
137
13Va
MEDICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH UL 60601-1CAN/CSA-C22.2 No. 601.1, ANSI/AAMI ES60601-1 (2005,
3rd ed.), CAN/CSA-C22.2 No. 60601-1 (2008),13VA
Keep Away
From Sunlight For Dental Use Only Keep Dry
www.dentsplysirona.com
www.dentsply.eu/ifu
50°C
122°F
Storage
Temperature
-20°C
4°F
Caution, consult
instructions for use Fragile Relative Humidity
%
5%
95%
Atmospheric
Pressure Limitation
80
kPa
106
kPa
5V-1A
137
13Va
Consult instructions for use
Keep Away
From Sunlight For Dental Use Only Keep Dry
www.dentsplysirona.com
www.dentsply.eu/ifu
50°C
122°F
Storage
Temperature
-20°C
4°F
Caution, consult
instructions for use Fragile Relative Humidity
%
5%
95%
Atmospheric
Pressure Limitation
80
kPa
106
kPa
5V-1A
137
13Va
Sterilizable up to the temperature specified
Keep Away
From Sunlight For Dental Use Only Keep Dry
www.dentsplysirona.com
www.dentsply.eu/ifu
50°C
122°F
Storage
Temperature
-20°C
4°F
Caution, consult
instructions for use Fragile Relative Humidity
%
5%
95%
Atmospheric
Pressure Limitation
80
kPa
106
kPa
5V-1A
137
13Va
Do Not Autoclave (Handpiece)
Do not re-use
Keep Away
From Sunlight For Dental Use Only Keep Dry
www.dentsplysirona.com
www.dentsply.eu/ifu
50°C
122°F
Storage
Temperature
-20°C
4°F
Caution, consult
instructions for use Fragile Relative Humidity
%
5%
95%
Atmospheric
Pressure Limitation
80
kPa
106
kPa
5V-1A
137
13Va
Dispose of in accordance with the Waste Electrical and Electronic Equipment Directive 2002/96/EC
of the European Parliament and the Council of the European Union
Keep Away
From Sunlight For Dental Use Only Keep Dry
www.dentsplysirona.com
www.dentsply.eu/ifu
50°C
122°F
Storage
Temperature
-20°C
4°F
Caution, consult
instructions for use Fragile Relative Humidity
%
5%
95%
Atmospheric
Pressure Limitation
80
kPa
106
kPa
5V-1A
137
13Va
Protection Class IPX0
IPX0 Classification of ingress of water for Charger – not protected
Keep Away
From Sunlight For Dental Use Only Keep Dry
www.dentsplysirona.com
www.dentsply.eu/ifu
50°C
122°F
Storage
Temperature
-20°C
4°F
Caution, consult
instructions for use Fragile Relative Humidity
%
5%
95%
Atmospheric
Pressure Limitation
80
kPa
106
kPa
5V-1A
137
13Va
Protection Class IPX1
IPX1 Classification of ingress of water
Keep Away
From Sunlight For Dental Use Only Keep Dry
www.dentsplysirona.com
www.dentsply.eu/ifu
50°C
122°F
Storage
Temperature
-20°C
4°F
Caution, consult
instructions for use Fragile Relative Humidity
%
5%
95%
Atmospheric
Pressure Limitation
80
kPa
106
kPa
5V-1A
137
13Va
Protection Class IPX3
IPX3 Classification of ingress of water for Handpiece - Protected against falling spray.
Keep Away
From Sunlight For Dental Use Only Keep Dry
www.dentsplysirona.com
www.dentsply.eu/ifu
50°C
122°F
Storage
Temperature
-20°C
4°F
Caution, consult
instructions for use Fragile Relative Humidity
%
5%
95%
Atmospheric
Pressure Limitation
80
kPa
106
kPa
5V-1A
137
13Va
Serial Number
Keep Away
From Sunlight For Dental Use Only Keep Dry
www.dentsplysirona.com
www.dentsply.eu/ifu
50°C
122°F
Storage
Temperature
-20°C
4°F
Caution, consult
instructions for use Fragile Relative Humidity
%
5%
95%
Atmospheric
Pressure Limitation
80
kPa
106
kPa
5V-1A
137
13Va
Batch Code/Lot Number
This symbol is a mandatory marking for devices entering the European market to indicate conformity with the essential health and
safety requirements set out in European Directives. The symbol may be
accompanied by a four-digit identification number of the notified body.
Keep Away
From Sunlight For Dental Use Only Keep Dry
www.dentsplysirona.com
www.dentsply.eu/ifu
50°C
122°F
Storage
Temperature
-20°C
4°F
Caution, consult
instructions for use Fragile Relative Humidity
%
5%
95%
Atmospheric
Pressure Limitation
80
kPa
106
kPa
5V-1A
137
13Va
Direct Current (DC) supply 5 Volts, 1 Amp

16
Keep Away
From Sunlight For Dental Use Only Keep Dry
www.dentsplysirona.com
www.dentsply.eu/ifu
50°C
122°F
Storage
Temperature
-20°C
4°F
Caution, consult
instructions for use Fragile Relative Humidity
%
5%
95%
Atmospheric
Pressure Limitation
80
kPa
106
kPa
5V-1A
137
13Va
Interference may occur in the vicinity of equipment marked with the following symbol
Date of Manufacture
8. DISPOSAL OF UNIT
U.S. - Dispose of the system components in accordance with state and local laws.
EU - Dispose of in accordance with the Waste Electrical and Electronic Equipment Directive 2002/96/EC of the European Parliament and the Council of
the European Union.
9. ELECTRO-MAGNETIC COMPATIBILITY PRECAUTION
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS
The digit Power® Dispenser is intended for use in the electromagnetic environment specified below. The Customer or the user of the digit Power®
Dispenser should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1 The digit Power® Dispenser uses RF energy only for its internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in nearby electronic equipment.
RF Emissions
CISPR 11
Class B The digit Power® Dispenser is suitable for use in all establishments, including domestic establishments and
those directly connected to the public low-voltage power supply network that supplies buildings used for
domestic purposes.
Warning: This equipment/system is intended for use by healthcare professionals only. This equipment/system
may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take
mitigation measures, such as re-orienting or relocating the digit Power® Dispenser or shielding the location.
Harmonic emissions
IEC 61000-3-2
Class B
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
The digit Power® Dispenser is intended for use in the electromagnetic environment specified below. The customer or the end user of the digit Power®
Dispenser should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electromagnetic
discharge (ESD)
IEC 61000-4-2
±8kV contact
±2, ±4, ±8, ±15kV air
±8kV contact
±2, ±4, ±8, ±15kV air
Floors should be wood, concrete or ceramic tile. If floors
are covered with synthetic material, the relative humidity
should be at least 30%.
Enclosure Port
IEC 61000-4-3
Tested as specified in Table 9 as
per IEC 61000-4-3
Tested as specified in Table 9 as
per IEC 61000-4-3
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
±0.5, ±1, ±2kV mains
No I/O lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV line(s) to line(s)
±2 kV line(s) to earth
±0.5, ±1kV Line to Line
±0.5, ±1, ±2kV Line to Earth
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % UT (>95 % dip in UT) f
or 0.5 cycle
40 % UT (60 % dip in UT)
for 5 cycles
70 % UT (30 % dip in UT)
for 25 cycles
<5 % UT (>95 % dip in UT)
for 5 sec
<5 % UT (>95 % dip in UT)
for 0.5 cycle
40 % UT (60 % dip in UT)
for 5 cycles
70 % UT (30 % dip in UT)
for 25 cycles
<5 % UT (>95 % dip in UT)
for 5 sec
Mains power quality should be that of a typical
commercial or hospital environment. If the user of the
digit Power® Dispenser requires handpiece charging
during power mains interruptions, it is recommended that
the digit Power® Dispenser charging base be powered
from an uninterruptible power supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial
or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

17
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS
The digit Power® Dispenser is intended for use in the electromagnetic environment specified below. The customer or the end user of the digit Power®
Dispenser should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 V
3 V/m
Portable and mobile RF communications equipment should be used no closer to any
part of the Medical Electric Equipment (digit Power® Dispenser), including cables, than
the recommended separation distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d = [3.5/V1] √P
d = [3.5/E1] √P 80 MHz to 800 MHz
d = [7/E1]√P 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer and d is the recommended separation distance in metres
(m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site
survey, a should be less than the compliance level in each frequency range.b Interference
may occur in the vicinity of equipment marked with the following symbol:
Keep Away
From Sunlight For Dental Use Only Keep Dry
www.dentsplysirona.com
www.dentsply.eu/ifu
50°C
122°F
Storage
Temperature
-20°C
4°F
Caution, consult
instructions for use Fragile Relative Humidity
%
5%
95%
Atmospheric
Pressure Limitation
80
kPa
106
kPa
5V-1A
137
13Va
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects
and people
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and
FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the digit Power® Dispenser
is used exceeds the applicable RF compliance level above, the digit Power® Dispenser should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the digit Power® Dispenser. b Over the frequency
range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE & MOBILE RF COMMUNICATIONS EQUIPMENT & THE MODEL
The medical electric equipment (digit Power® Dispenser) is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled.
The customer or the user of the digit Power® Dispenser can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the medical electric equipment (digit Power® Dispenser) as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter m
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using
the equation applicable to the frequency of the transmitter, where P is the maximum output rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects
and people.
d= [ ] √P
3.5
E1
d= [ ] √P
3.5
E1d= [ ] √P
7
E1

18
POWER INPUT AND FREQUENCIES
Input 100-240V~, 50-60 Hz, 0.3A
Output Direct Current (DC) supply 5 Volts, 1 Amp
• This device complies with Part 15 of the FCC Rules and with Industry Canada license-exempt RSS standard(s). Operation is subject to the following
two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference
that may cause undesirable operation.
• This Class B digital apparatus complies with Canadian ICES-003.
• Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for
the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the
equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication.
• This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate
radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio
or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by
one or more of the following measures:
o Reorient or relocate the receiving antenna.
o Increase the separation between the equipment and receiver.
o Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
10. TROUBLESHOOTING
PROBLEM SOLUTION
Optional Wireless Foot Control
does not charge.
1. Ensure that the power cord is securely attached to the wall outlet and the optional wireless foot control.
2. Remove the optional wireless foot control access door and look in the compartment; ensure that the LED in the
bottom compartment is illuminated. If not, call Technical Support.
System intermittently shuts down. 1. Handpiece may shutdown in the presence of strong non-compliant Radio Frequency generating components
(interference).
2. Call Technical Support.
Handpiece does not have the
correct speed control.
1. Handpiece or optional wireless foot control may be malfunctioning.
2. Call Technical Support.
Difficulty removing cartridge cap
from handpiece.
1. Check the components for gross debris.
2. Hold the handpiece securely, press both locking tabs and pull straight off. Do not twist cartridge cap while
removing.
3. Ensure both locking tabs are depressed before removing cartridge cap.
4. Inspect parts for wear.
5. Call Technical Support.
Charging base for the handpiece
does not drain liquids.
Clear any debris from the hole at the bottom of the charging base for handpiece.
Handpiece does not charge. 1. Clean the charge contacts on the handpiece and charging base for handpiece using one of the approved cleaning
solutions described in section 4. Do not spray cleaning solutions directly onto parts.
2. Verify that the power supply is properly connected to the charging base for handpiece and that the green LED
on back lights up.
3. Verify that the handpiece is able to properly sit inside the charging base for handpiece, and that there are no
foreign obstructions.
4. If still not charging, call Technical Support.
Handpiece does not hold charge. 1. Verify that the handpiece properly charges (Battery icon flashes and scrolls when in the charger).
2. Call Technical Support.
Power supply overheating. Immediately unplug the unit and call Technical Support.
Power cord is frayed or damaged
in any way.
Do not use. Call Technical Support.

19
11. SERIAL NUMBER
The digit Power® Dispenser, charging base and foot control have different serial numbers located on their respective bodies. These serial numbers should
be included in all correspondence.
12. WARRANTY
The Dentsply Sirona digit Power® Dispenser is designed exclusively for dental use and this warranty is not applicable to other uses. This warranty extends to digit
Power® Dispenser system purchased from an authorized Dentsply Sirona distributor, and only to the original purchaser.
All components of the digit Power® Dispenser are warranted for (1) year from the date of purchase against defects arising from faulty materials and workmanship.
Parts will be repaired or replaced at the discretion of Dentsply Sirona provided that the system has been operated and maintained as prescribed in these
instructions and has not been subjected to apparent misuse, abuse or accident. Claims covered by this warranty will be honored when presented through your
Dentsply Sirona distributor within thirty (30) days from discovery of defect within the applicable warranty period.
THERE ARE NO WARRANTIES, EXPRESS OR IMPLIED, WHICH EXTEND BEYOND THE DESCRIPTION ON THE FACE HEREOF. Dentsply Sirona neither assumes,
nor authorizes any person to assume for it, any other liability in connection with the sale or use of its products. DAMAGES ARE LIMITED STRICTLY TO REPAIR OR
REPLACEMENT OF PARTS. DENTSPLY EXPRESSLY DISCLAIMS LIABILITY FOR INCIDENTAL AND CONSEQUENTIAL DAMAGES RESULTING FROM THE USE OF
THE PRODUCTS.
13. TECHNICAL SUPPORT
For technical support, please contact the numbers below or your local Dentsply Sirona Sales Office directly:
United States of America
Dentsply Sirona Preventive
Technical Service and Repair Department
1301 Smile Way
York, PA 17404-1785
Phone: [phone] or [phone]
UK
Dentsply Sirona Service Centre
Brunel Way, Stroudwater Business Park
Stonehouse, Gloucestershire GL10 3GB
United Kingdom
Phone: [phone]
Germany
Dentsply DeTrey GmbH
De-Trey-Strasse 1
78467 Konstanz
Germany
Phone: [phone] (for Germany)
Phone: [phone] (for Austria)
Canada
Dentsply Sirona Canada
161 Vinyl Court
Woodbridge Ontario
L4L 4A3 Canada
Phone: [phone]
Australia
Dentsply Sirona Australia
11-21 Gilby Road
Mount Waverly, Victoria 3149
Australia
Phone: [phone]

20
1. DESCRIPCIÓN DEL PRODUCTO
El dispensador digit Power® es una pieza de mano accionada por batería
para la aplicación intraoral precisa de materiales dentales suministrados
a través de los cartuchos digit Power®. El dispensador está diseñado para
mejorar la ergonomía de la dispensación del material en comparación con
los sistemas mecánicos convencionales, y permitir al mismo tiempo una
aplicación intraoral sencilla y precisa de los materiales dentales. El diseño
del dispensador digit Power® integra portabilidad y versatilidad gracias a
una batería de larga vida útil, a las múltiples opciones de velocidad en la
pieza de mano y a un pedal de control inalámbrico Bluetooth® opcional
para una velocidad totalmente variable.
El dispensador digit Power® lleva incorporado un temporizador de
activación automática que permite controlar cómodamente el tiempo de
trabajo del material durante la dispensación (WORK TIME), y el tiempo
de fraguado/tiempo de extracción de la boca (SET TIME/MRT). Los
modos programados del temporizador se corresponden con el FAST
SET (fraguado rápido) y el REG SET (fraguado normal) del material de
impresión Aquasil® Ultra+ Smart Wetting®. La pieza de mano incluye
también una práctica opción de temporizador especificada por el usuario.
1.1 INDICACIONES
El dispensador digit Power® está indicado para la aplicación intraoral de
materiales suministrados en los cartuchos digit Power®.
El dispensador digit Power® es perfecto para:
• La aplicación del material de impresión de baja viscosidad Aquasil Ultra+
Smart Wetting® suministrado en los cartuchos digit Power® para la
técnica de impresión de una o varias preparaciones.
1.2 CONTRAINDICACIONES
Ninguna conocida hasta la fecha.
1.3 FORMAS DE PRESENTACIÓN
*Es posible que algunas presentaciones no estén disponibles en todos los
países
El dispensador digit Power® está disponible como una unidad completa,
con un soporte para la carga de la batería.
Componentes del producto:
• Pieza de mano
• Tapa del cartucho desmontable y esterilizable en autoclave
• Base de carga
• Fuente de alimentación conectable a una toma de pared
• Adaptadores de alimentación internacionales
Accesorios disponibles:
• Pedal de control inalámbrico para el control de la velocidad de
dispensación
• Fundas de barrera de polietileno desechables
1.4 MATERIALES COMPATIBLES
El dispensador digit Power® es compatible con los materiales suministrados
en los cartuchos digit Power®.
Los materiales que no se suministran en los cartuchos digit Power® no
están previstos para su uso con el dispensador digit Power®.
Consulte en las instrucciones de uso completas del material seleccionado la
compatibilidad y el uso.
2. NOTAS GENERALES DE SEGURIDAD
Tenga en cuenta las siguientes notas generales de seguridad.
Símbolo de alerta de seguridad
Este es el símbolo de alerta de seguridad. Se utiliza para avisarle
de posibles riesgos de daños personales. Observe todos los
mensajes de seguridad que sigan a este símbolo para evitar
posibles daños.
Índice
1. DESCRIPCIÓN DEL PRODUCTO .....................20
1.1 Indicaciones
.....................................
20
1.2 Contraindicaciones
..............................
20
1.3 Formas de Presentación
.........................
20
1.4 Materiales Compatibles ........................... 20
2. NOTAS GENERALES DE SEGURIDAD .................
20
2.1 Advertencias ....................................21
2.2 Precauciones
...................................
21
2.3 Reacciones adversas ............................. 21
2.4 Condiciones de conservación ..................... 21
3. INSTRUCCIONES PASO A PASO ..................... 22
3.1 Descripción del dispensador digit Power ...........22
3.2 Desembalaje del sistema ......................... 23
3.3 Instalación del dispensador digit Power
...........
23
3.4. Carga de la pieza de mano y del pedal de control
inalámbrico opcional ............................23
3.5 Sincronización de la pieza de mano y del pedal de
control inalámbrico opcional .....................24
3.6. Preparación para el uso
.........................
24
3.7 Carga del dispensador digit Power ................ 27
3.8 Manejo del dispensador .......................... 27
3.9 Desmontaje del dispensador /
retracción de los émbolos .......................29
4. IGIENE Y MANTENIMIENTO
........................
29
5. ESPECIFICACIONES TÉCNICAS
.....................
32
6. CLASIFICACIONES ................................ 33
7. IDENTIFICACIÓN DE LOS SÍMBOLOS .................
33
8. ELIMINACIÓN DE LA UNIDAD .......................
34
9. PRECAUCIONES RELATIVAS A LA COMPATIBILIDAD
ELECTROMAGNÉTICA ...........................35
10. SOLUCIÓN DE PROBLEMAS .......................
37
11. NÚMERO DE SERIE
...............................
38
12. GARANTÍA ...................................... 38
13. SERVICIO TÉCNICO
..............................
38
MANUALD E USO – ESPAÑOL
Atención: Exclusivamente para uso dental.
EE. UU: Solo con receta médica.
Dispensador digit Power®